Shares in Novavax (NVAX) surged 7% in Thursday’s after-hours trading, after the late-stage biotech announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its NVX-CoV2373 Covid-19 vaccine candidate.
The trial will take place in the UK, with the help of the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 years of age, over the next four to six weeks.
“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said NVAX’s Gregory M. Glenn.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries” he added.
NVX-CoV2373 is a stable, prefusion protein made using Novavax’s recombinant protein nanoparticle technology and MatrixM adjuvant. According to Novavax, the adjuvant should enhance the immune response and stimulate high levels of neutralizing antibodies.
The vaccine can also be handled in an unfrozen, liquid formulation, allowing for distribution using standard vaccine channels.
In the meantime, Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.
In the Phase 3 trial, half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.
The trial is designed to enroll at least 25% of participants over the age of 65 as well as to prioritize groups that are most affected by Covid-19, including racial and ethnic minorities. (See Novavax stock analysis on TipRanks).
Shares in NVAX have spiked by an incredible 2,475% year-to-date. “With the large-scale manufacturing and global supply arrangements being put in place, we believe NVAX is well poised to catch up to its more advanced peers” cheers B Riley FBR analyst Mayank Mamtani.
He has a buy rating on NVAX and $257 price target, indicating shares can surge a further 150% from current levels.
Overall, the stock scores a Moderate Buy analyst consensus based on 4 recent buy ratings vs 1 sell rating. The average analyst price target works out at $228 (122% upside potential).
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